Trifluoperazine Hydrochloride (Page 4 of 4)

Elderly Patients

In general, dosages in the lower range are sufficient for most elderly patients. Since they appear to be more susceptible to hypotension and neuromuscular reactions, such patients should be observed closely. Dosage should be tailored to the individual, response carefully monitored, and dosage adjusted accordingly. Dosage should be increased more gradually in elderly patients.

Non-Psychotic Anxiety

Usual dosage is 1 mg or 2 mg twice daily. Do not administer at doses of more than 6 mg per day or for longer than 12 weeks.

Schizophrenia

Oral

Usual starting dosage is 2 mg to 5 mg b.i.d. (Small or emaciated patients should always be started on the lower dosage.)

Most patients will show optimum response on 15 mg or 20 mg daily, although a few may require 40 mg a day or more. Optimum therapeutic dosage levels should be reached within 2 or 3 weeks.

DOSAGE AND ADMINISTRATION-SCHIZOPHRENIA IN CHILDREN

Dosage should be adjusted to the weight of the child and severity of the symptoms. These dosages are for children, ages 6 to 12, who are hospitalized or under close supervision.

Oral

The starting dosage is 1 mg administered once a day or b.i.d. Dosage may be increased gradually until symptoms are controlled or until side effects become troublesome.

While it is usually not necessary to exceed dosages of 15 mg daily, some older children with severe symptoms may require higher dosages.

HOW SUPPLIED

Trifluoperazine Hydrochloride Tablets, USP are available containing trifluoperazine hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg or 10 mg of trifluoperazine.

The 1 mg tablets are white film-coated, round, unscored tablets debossed with T3 on one side of the tablet and M on the other side.

The 2 mg tablets are white film-coated, round, unscored tablets debossed with T4 on one side of the tablet and M on the other side.

For psychiatric patients who are hospitalized under close supervision.

The 5 mg tablets are lavender film-coated, round, unscored tablets debossed with T5 on one side of the tablet and M on the other side.

The 10 mg tablets are lavender film-coated, round, unscored tablets debossed with T6 on one side of the tablet and M on the other side.

They are supplied by State of Florida DOH Central Pharmacy as follows:

NDC	Strength	Quantity/Form	Color	Source Prod. Code
53808-0629-1	2 mg	30 Tablets in a Blister Pack	WHITE	0378-2402
53808-0819-1	10 mg	30 Tablets in a Blister Pack	lavender	0378-2410

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States

PACKAGE LABEL

Label Image for 53808-0629 2mg

Label Image for 2mg

PACKAGE LABEL

Label Image for 53808-0819 10mg

Label Image for 10mg

TRIFLUOPERAZINE HYDROCHLORIDE trifluoperazine hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53808-0629(NDC:0378-2402) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRIFLUOPERAZINE HYDROCHLORIDE (TRIFLUOPERAZINE) TRIFLUOPERAZINE 2 mg

Inactive Ingredients Ingredient Name Strength COLLOIDAL SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS STARCH, CORN SODIUM LAURYL SULFATE TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color WHITE Score no score Shape ROUND Size 8mm Flavor Imprint Code M;T4 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:53808-0629-1 30 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040209 01/01/2013

TRIFLUOPERAZINE HYDROCHLORIDE trifluoperazine hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53808-0819(NDC:0378-2410) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRIFLUOPERAZINE HYDROCHLORIDE (TRIFLUOPERAZINE) TRIFLUOPERAZINE 10 mg

Inactive Ingredients Ingredient Name Strength COLLOIDAL SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS STARCH, CORN SODIUM LAURYL SULFATE TITANIUM DIOXIDE TRIACETIN D&C RED NO. 30 FD&C BLUE NO. 2 FD&C YELLOW NO. 6

Product Characteristics Color PURPLE (lavender) Score no score Shape ROUND Size 10mm Flavor Imprint Code M;T6 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:53808-0819-1 30 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040209 01/01/2013

Labeler — State of Florida DOH Central Pharmacy (829348114)

Establishment
Name	Address	ID/FEI	Operations
State of Florida DOH Central Pharmacy		829348114	repack (53808-0629), repack (53808-0819)

Revised: 09/2013 State of Florida DOH Central Pharmacy